Specialist Quality Complaints

Weil Group • Juncos, PR

17h

About The Position

We are looking for a proactive Specialist to lead our quality complaint investigations. You will be responsible for reviewing feedback, driving root-cause analysis, and ensuring compliance with industry regulations. Bring your analytical skills and attention to detail, and help us build better products every day.

Requirements

• Strong project management skills
• Experience leading cross-functional teams
• Ability to handle multiple projects simultaneously
• Excellent written and verbal communication skills, including facilitation and presentation skills.
• Able to work in a team-oriented, matrix environment and work effectively with diverse departmental groups.
• Be self-motivated, able to interface effectively with various levels, attentive to details and able to prioritize and meet deadlines
• Excellent leadership, problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment.
• Computer literacy
• Independently understand, follow and implement instructions
• Work independently or as a team player and collaborate with outside resources
• Ability to evaluate issues, make decisions and determine when to escalate, as necessary.

Nice To Haves

• Candidate must possess excellent writing skills that include closing the gap between a highly technical investigation into a simple and concise document that can be understood by non-technical reviewers.

Responsibilities

• Supporting the product complaint system through; leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner.
• Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately.
• Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations.
• Follow-up on corrective actions derived from investigations through completion.
• On occasion, depending on the nature and complexity of the complaint, the specialist may be responsible of conducting and documenting the investigation.
• Communication and escalation of complaints, site representation on the product complaint network and generation and issuance of closure letters to patients and business partners.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level